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SESSION 11: Biosimilars
Session Chair(s)
Ali AlSamil
Head of Biotech and Biosimilar Products Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia
SESSION 10: Biosimilars
Speaker(s)
Introduction & Setting the Scene – Evolution and Global Efforts (IPRP and ICH)
Ali AlSamil
Head of Biotech and Biosimilar Products Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Mohammed H. Aldosari, PhD
Director of Biological Products Directorete, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Anne Cook
Expert Quality Assessor (Biologicals) Healthcare, Quality and Access group, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Andrea Laslop, MD
Former Head of Scientific Office, AGES & Regulatory expert, lecturer, Malta Medicines Authority, University of Innsbruck, Austria
Industry Perspective
Virginia Acha
AVP, Science and Regulatory Policy, Merck & Co., Inc., United Kingdom
Panel Discussion with Q&A (With the additional participation of):
Panellist(s) Invited
, Qatar
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